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【EXPERT Q&A】What are the differences in the registration application requirements for in vitro diagnostic (IVD) medical devices between China and the European Union?

Drugdu.com expert’s response: Differences in Registration Application Requirements for In Vitro Diagnostic (IVD) Medical Devices between China and the European Union The differences in registration application requirements for IVD medical devices between China and the European Union are mainly reflected in classification rules, conformity assessment paths, technical documentation requirements, quality management systems, clinical evaluations, and post-market surveillance and traceability. Here is a detailed introduction: I. Classification Rules China: Based on risk, IVD products are classified into Class I, II, and III. The classification rules are relatively clear, with reference to the detailed “Classification Catalog of In Vitro Diagnostic Reagents.” European Union (IVDR): Based on risk, IVD products are classified into Class A, B, C, and D (with risk increasing from low to high). The classification rules are more refined and stricter, following the rules in Annex VIII. A key change under the IVDR is that a large number of products ...
- Source: drugdu
- 137
- March 16, 2026
Fangda Pharma helps Jiminke’s Class 1 innovative drug, Jilemei®, obtain market approval.

Recently, Jilemei® (soximerexyl sulfate tablets), a Class 1 innovative drug supported by Fangda Pharmaceutical (Suzhou) Co., Ltd. in the clinical stage, has been granted priority review and approval by the National Medical Products Administration and conditionally approved for marketing . Developed by Zhejiang Hangyu Pharmaceutical, a subsidiary of Jiming Kexin , this drug is intended to treat adult patients with advanced non-small cell lung cancer ( NSCLC ) with murine sarcoma virus oncogene ( KRAS ) G12C mutation who have received at least one systemic therapy , providing a new treatment option for this lung cancer subtype with a well-defined molecular target. As a partner, Fangda’s team completed the production , quality release, and stability studies of Phase I and Phase II clinical samples , and provided integrated services such as clinical double-blind labeling , sample storage management , clinical drug delivery, and international transportation . With its efficient, professional, ...
- Source: drugdu
- 129
- March 13, 2026
Dexamethasone API Marketing Application Approved

March 13th – Cyto BiotechThe announcement stated that the company’s controlling subsidiary, Shandong Srui Pharmaceutical Co., Ltd., received a certificate from the National Medical Products Administration for dexamethasone, a chemical raw material.”Notification of Approval for Drug Marketing Application”. Dexamethasone is a long-acting glucocorticoid with anti-inflammatory, anti-allergic, and immunosuppressive effects. It is mainly used for allergic and autoimmune inflammatory diseases, such as connective tissue diseases, severe bronchial asthma, dermatitis, ulcerative colitis, acute leukemia, and malignant lymphoma. https://finance.eastmoney.com/a/202603133671477849.html
- Source: drugdu
- 106
- March 13, 2026
China’s first innovative drug prescription based on precise postoperative assessment for thyroid cancer

On March 11, China’s first innovative drug　　for precise postoperative assessment of differentiated thyroid cancer was launched.Human thyroid-stimulating hormone beta (Zesuning) for injection at the First Affiliated Hospital of Zhejiang University School of MedicineThe first prescription was issued by Jiangsu Provincial People’s Hospital . Thyroid cancer is one of the fastest-growing solid tumors in recent years. Differentiated thyroid cancers, such as papillary carcinoma and follicular carcinoma, account for over 90% of cases. These tumors generally have a good prognosis, with a 10-year survival rate exceeding 90%. However, a high survival rate does not mean “no management is needed.” Studies show that approximately 10%-30% of patients still face the risk of recurrence or metastasis during postoperative follow-up. Therefore, regular and standardized postoperative follow-up to monitor for residual lesions or signs of recurrence is crucial for improving the long-term quality of life for these patients. For patients who have undergone total resection of ...
- Source: drugdu
- 105
- March 13, 2026
The launch meeting for the research project on innovative chemical drugs for Alzheimer’s disease was held.

On the afternoon of March 12, an innovative drug led by the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, was launched.The launch meeting for the National Science and Technology Major Project on Drug Development, ” Research on Innovative Chemical Drugs for Anti-Alzheimer’s Disease Targeting New Mechanisms,” was held in Shanghai. This meeting was conducted strictly in accordance with the special project management standards, systematically deploying the project’s overall objectives, technical roadmap planning, task allocation, clinical research layout, and funding management throughout the entire process. (Wanbangde)(002082) The wholly-owned subsidiary Wanbangde Pharmaceutical Group, together with the project lead unit, cooperating research institutions and industry experts, gathered together to discuss the details of the project implementation and build consensus on research and development. Alzheimer’s disease is the most common type of dementia in clinical practice and also the most prevalent neurodegenerative disease. Its main manifestations include progressive decline in memory, judgment, ...
- Source: drugdu
- 195
- March 13, 2026
Announcement Regarding the Inclusion of its Innovative Drug HSK31679 Tablets in the Breakthrough Therapy Program

March 12 – Harscon Pharmaceutical…The company announced that on March 12, 2026, it learned that HSK31679 tablets were officially included in the “Breakthrough Therapy List” by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, making it the first THR-β agonist to be included in the Breakthrough Therapy List in China. Currently, no drugs are approved in China for the treatment of MASH (non-alcoholic steatohepatitis). The inclusion of HSK31679 tablets in the “Breakthrough Therapy List” will greatly promote the research and development of new drugs in this field and bring new hope for the treatment of MASH patients in my country. https://finance.eastmoney.com/a/202603123670377648.html
- Source: drugdu
- 123
- March 13, 2026
【EXPERT Q&A】How can the stability study of in vitro diagnostic reagents under the EU IVDR be carried out efficiently?

Drugdu.com expert’s response: To efficiently conduct stability studies of in vitro diagnostic reagents within the framework of the EU’s In Vitro Diagnostic Regulation (IVDR), it is essential to systematically advance from five perspectives: regulatory compliance, study design, implementation and execution, data management and analysis, and continuous improvement. The specifics are as follows: 1. Regulatory Compliance: Precisely Align with IVDR Requirements Core Regulations and Guidelines: IVDR Regulation: As the cornerstone of EU regulations for in vitro diagnostic reagents, IVDR specifies the fundamental requirements for stability studies, including study objectives, types, and data submission. EN ISO 23640:2015: This standard provides detailed guidelines for the stability evaluation of in vitro diagnostic reagents, covering experimental design, evaluation procedures, and reporting requirements, serving as a crucial reference for stability studies. CLSI EP25-A: Targeting quantitative/qualitative reagents, CLSI EP25-A encompasses the design of stability testing plans, data analysis, transportation assessment, and the application of accelerated testing, offering specific ...
- Source: drugdu
- 125
- March 13, 2026
SHR-9803 for Injection Approved for Clinical Trials

On March 11, Hengrui Medicine (600276/01276) issued an announcement stating that the company recently received the “Drug Clinical Trial Approval Notice” for SHR-9803 for injection issued by the National Medical Products Administration, and will conduct clinical trials in the near future. This drug is a Class 1 therapeutic biological product.It can activate anti-tumor immune activity, specifically bind to and eliminate regulatory T cells within tumors, while reducing the impact on peripheral Tregs, aiming to improve the safety and efficacy of tumor treatment. To date, the cumulative R&D investment in SHR-9803 injection-related projects is approximately RMB 18.3 million (unaudited). In the first three quarters of 2025, Hengrui Medicine achieved revenue of RMB 23.188 billion and net profit attributable to the parent company of RMB 5.751 billion. https://finance.eastmoney.com/a/202603113668880571.html
- Source: drugdu
- 111
- March 12, 2026
Invests 5 million yuan to participate in the establishment of an investment fund to expand into the biopharmaceutical field

Lumay Pharmaceutical(300006) announced on March 12 that the company recently signed an agreement with Xi’an Wojie Private Equity Fund Management Co., Ltd. and Sansure Biotech.Several institutions, including a technology company, signed a partnership agreement to jointly establish Guangzhou Shengquan Baijie Venture Capital Fund Partnership (Limited Partnership). The fund aims to raise a total of RMB 150 million, of which the company, as a limited partner, will contribute RMB 5 million from its own funds, representing a 3.33% stake. The investment fund primarily invests in innovative biopharmaceuticals and medical devices .In vitro diagnosticsIn the life and health sectors, investments in these industries shall not be less than 60% of the fund’s total paid-in capital. The fund focuses on investing in Guangzhou’s strategic emerging industries and future industries, and has established a fund for seed companies in Guangzhou.Investment ratio requirements for early-stage and angel-stage projects. According to the announcement, the company’s investment ...
- Source: drugdu
- 110
- March 12, 2026
Huadong Medicine’s clinical trial application for injectable HDM2024 drug has been approved by the US FDA

March 11, Huadong Medicine…(000963) issued an announcement stating that its wholly-owned subsidiary, Hangzhou Sino-American East China Pharmaceutical Co., Ltd. (hereinafter referred to as “Sino-American East China”), received a notification from the U.S. Food and Drug Administration (hereinafter referred to as “FDA”) that the clinical trial application for injectable HDM2024 submitted by Sino-American East China has been approved by the U.S. FDA and can be carried out in the United States for Phase I clinical trials, with the indication being advanced solid tumors. Huadong Medicine stated that the approval of the US clinical trial of injectable HDM2024 is another important step in the product’s development process and will further enhance the company’s core competitiveness in the field of oncology treatment. https://finance.eastmoney.com/a/202603113668988846.html
- Source: drugdu
- 114
- March 12, 2026

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